Fujifilm Corporation

CLOSEOUT LETTER Fujifilm Corporation MARCS-CMS 546987 — April 04, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Henry Izawa Recipient Title President and CEO Fujifilm Corporation 419 West Avenue Stamford , CT 06902 United States Issuing Office: Center for Devices and Radiological Health United States Dear Henry Izawa: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546987, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely yours, /S/ Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Center for Devices and Radiological Health CC: Randy Vader Vice President, Quality and Regulatory Affairs and Corporate Compliance Officer Fujifilm Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Keith Nelson Director of Infection Control and Quality Assurance 10 Highpoint Drive Wayne, New Jersey 07470 Mr. Teiichi Goto Corporate Vice President General Manager Medical System Business Division Research & Development Management Headquarters Fujifilm Corporation 798, Miyanodai Kaisei-Machi Ashigarakami-Gun Kanagawa 258-8538 Japan Jennifer Henderson Partner, Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 John J. Smith, MD, JD Legal Counsel at Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004US AGENT US AGENT ADDRESS Content current as of: 04/08/2022 Regulated Product(s) Medical Devices